CN100394939C - Pure Chinese medicine oral preparation for treating prostate disease and its preparation metod - Google Patents
Pure Chinese medicine oral preparation for treating prostate disease and its preparation metod Download PDFInfo
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Abstract
The present invention relates to an oral preparation of a pure traditional Chinese medicine for treating prostate diseases and a preparation method thereof. The oral preparation is prepared from raw materials of amur corktree bark, radix paeoniae rubra, danshen root, peach seed, hiraute shiny bugleweed herb, combined spicebush root, cowherb seed and dahurian angelica, and is prepared by extracting effective components from raw materials and adjusting safety using amounts. The oral preparation of the present invention is mainly used for treating chronic prostatitis, benign prostate hyperplasia and other usual andriatry diseases in clinic practice, and has the characteristics of security, high efficiency and quick efficiency.
Description
Technical field
The invention belongs to medicine field, relate to a kind of pure oral preparation of Chinese traditional medicinal and preparation technology thereof who treats prostatosis
Background technology
The two etiology of prostatitis and prostatic hyperplasia all fails very to check on, and the two seemingly has cause effect relation, but does not see the reported literature of cogency.The clinical findings pathological replacement, the many existence of all prostate hyperplasia persons with inflammation.So the old prostate hyperplasia of male is many with prostatitis, the two is also deposited.
At present, the treatment of prostatitis and prostatic hyperplasia still there is not specific short.All kinds of antibiotic and urinary system anti-infective, though prostatitis is had certain short term effect, relapse rate is high, and heals than refractory after forming chronic prostatitis.It is once voguish both at home and abroad in the 30-50 age that the Drug therapy of prostatic hyperplasia is used estrogen, still has the people to use so far.Also really can the respite dysuria, but that side effect is a gastrointestinal reaction is very big, influences appetite, breast hypertrophy pain discomfort.And take medicine more for a long time, easily cause prostate and surrounding tissue adhesion tension, cause the peeling operation difficulty, hemorrhage more.So after the seventies, clinical few the using that be tending towards trying one's best.Because the development of receptor theory widely applies α receptor blocking agent such as diphenazoline etc. that prostatic hyperplasia patient long-term (about 5 years) is used, receive rather satisfied effect abroad in recent years, but very big to the influence of blood pressure.So hypertension and cardiopathic patient forbidding is arranged.And with the logical price comparison costlinesses such as (Germany's systems) of the urine of this medicine and import, be difficult to promote.The QIANLIEKANG of present domestic use (sheet, capsule) is though its curative effect of the short report of finding is good
[1]But produce effects is very slow, needs clothes of a specified duration just can take effect, and once sees the report that causes oral mucosal ulceration after taking
[2], its reason may be the anaphylaxis due to the pollen.So the prostatitic medicine of treatment waits further exploitation.
Chronic prostatitis and hyperplasia of prostate belong to " stranguria ", " nebulousurine " category of the traditional Chinese medical science, and clinical manifestation mostly is urinates not wellly, and it is short unclear to drown, and pains in the penis are itched, the urine back sound of rain pattering, abdomen acid distending pain or take out pain, giddy, dim eyesight, impotence etc.According to tcm theory with Shanghai Stock Exchange's feelings its because of many with damp and hot relevant, often excessive because of impairment caused by overstrain, intemperate sexual intercourse etc. cause suffering from a deficiency of the kidney, disturbance in functioning of QI, endogenous damp formation.Or because of depressed rage impairing the liver, Liver Channel stagnation of QI-blood, strongly fragrant and heat-transformation makes the damp-heat accumulation part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels and falls ill.Treat this sick working as with clearing away heat-damp and promoting diuresis, the blood circulation promoting and blood stasis dispelling detumescence, the promoting the circulation of QI warming middle-JIAO to relieve pain is main.The present invention is made up of eight flavor Chinese medicines such as Radix Paeoniae Rubra, Cortex Phellodendri.Radix Paeoniae Rubra removing heat from blood and promoting blood circulation in the side; Cortex Phellodendri is rushed down the kidney fire, clear damp-heat in lower-JIAO is a principal agent.Assistant is with blood stasis dispersing and deswellings such as Radix Salviae Miltiorrhizaes, and diuretic stimulates the menstrual flow; Be equipped with circulation of qi promoting cold expelling, regulating QI to relieve pain such as the Radix Linderae again.Full side forms tight, gives prominence to the key points.Purposiveness is clear and definite.Clinical practice proves, this medicine has better curative effect to the disease of all kinds of stranguria with turbid discharge, especially to the not well person of puckery pain that urinates, short unclear person drowns, button sound of rain pattering person is itched, urinated to pains in the penis, lower abdomen acid distending pain or take out pain person, and the part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels loses incubative pathogen of a specified duration and does not go the person, obstinate is sent out survivor etc. for the anti-difficulty in urination, takes this medicine and all can obtain well the good effect of preventing, controlling.
Summary of the invention
The object of the present invention is to provide a kind of pure oral preparation of Chinese traditional medicinal for the treatment of prostatosis; The present invention also aims to provide a kind of preparation technology who treats the pure oral preparation of Chinese traditional medicinal of prostatosis.
Crude drug of the present invention consists of:
Cortex Phellodendri 8～12 weight portion Radix Paeoniae Rubra 8～12 weight portion Radix Salviae Miltiorrhizaes 3～7 weight portions
Semen Persicae 5～9 weight portion Herba Lycopi 4～8 weight portion Radixs Linderae 4～8 weight portions
Semen Vaccariae 2～6 weight portion Radixs Angelicae Dahuricae 2～6 weight portions
Above-mentioned composition can be made clinical acceptable peroral dosage form and comprise oral liquid, tablet, capsule, soft capsule, granule, medicated wine, pill, powder etc.
Preparation method of the present invention can be any one in the following method:
1, it is standby to be broken into fine powder; Get Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae, when the Radix Angelicae Dahuricae is heated to 80 ℃, add Semen Persicae, continue heating, decoct 3-4 time, each 1-2 hour, collecting decoction filtered, and filtrate is condensed into thick paste, and drying is ground into fine powder; Adding Cortex Phellodendri fine powder is made clinical acceptable peroral dosage form and is comprised oral liquid, tablet, capsule, soft capsule, granule, medicated wine, pill, powder etc.
2, it is standby to be ground into fine powder; Get the Radix Linderae, Herba Lycopi, the Radix Angelicae Dahuricae three flavor medicines and extract volatile oil by steam distillation, raffinate is waited until alcohol,diluted and is used, residue mixes with Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Semen Vaccariae, adding water temperature earlier soaked 5-7 hour, adding Semen Persicae when adding water to 80 degree centigrade again continues to decoct 3-4 time, add water is dosage 4-8 times at every turn, decocts 1-2 hour, and it is stand-by to merge filtration simmer down to extractum; Volatile oil and extractum are mixed, and oven dry adding Cortex Phellodendri fine powder is made clinical acceptable peroral dosage form and is comprised oral liquid, tablet, capsule, soft capsule, granule, medicated wine, pill, powder etc.
Medicine of the present invention is through clinical application for many years, and 421 routine patient's observed results are shown the waiting time of urinating, the urine flow rate variation, number of micturitions, residual urine volume and sexual function etc. all are significantly improved, medication treatment anteroposterior diameter ultrasound diagnosis prostate volume dwindles really, and clinical efficacy is excellent, and does not find toxic and side effects.So further inquire into its pharmacodynamics and toxicology, the result proves that this medical instrument has effects such as antiinflammatory, analgesia, calmness, and clinical efficacy is definite, is that present prostatic hyperplasia is with the comparatively ideal control medicine of chronic inflammatory disease.
Experimental example:The rat prostate hypertrophy that adopts androlin to cause is observed prostatic hyperplasia degree and pharmacological action of the present invention.
Test method
1, the present invention is to the effect of prostatic hyperplasia model
Select body weight 180g ± 20g male rat for use, under sterile working's rules, the excision bilateral testes after one week, is divided into 6 groups at random with rat, and 10 every group, (1) normal control group; (2) model group: subcutaneous injection is dissolved in androlin 0.1ml/200g/ of olive oil; (3) 1g/kg of the present invention; (4) 2g/kg of the present invention; (5) 3g/kg of the present invention; (6) positive control: estradiol benzoate 50 μ g/kgS c, except that normal control, all the other 5 groups of rat subcutaneous injection every day androlin 0.1ml/200g/ are (0.5mg/kg) only, injected altogether 30 days, gastric infusion is pressed above dosage gastric infusion every day once simultaneously, and normal control group and model group are irritated stomach equal-volume distilled water 10ml/kg, successive administration 30 days, behind last medication 24h, weigh, put to death animal and win prostate and seminal vesicle simultaneously, claim weight in wet base, calculate prostate and the dirty body ratio of seminal vesicle, other gets prostata tissue, cuts into slices as pathology and observes it in microscopically and now manage morphological change, and measure epithelioglandular height, glandular cell chamber diameter.
2, the influence of auricular concha inflammation due to the xylol
Mice ICR kind, male, divide 5 groups at random, matched group gives to wait the tap water of capacity; Aspirin group 0.1g/kg; Of the present invention group of 1g/kg, 2g/kg, 3g/kg, each group is irritated stomach respectively, for three days on end, and after administration on the 4th 1 hour, two of each mouse right ear back of the body melted paraxylenes, animal takes off neck and puts to death after 30 minutes, cuts two ears along the auricle baseline, weighs.Left side ear is the contrast ear, with the heavy difference of two auricles as the inflammatory swelling level index.
Result of the test,
1, to the effect of experimental prostatic hyperplasia
Prostate model group prostate and seminal vesicle index obviously increase, and compare with matched group that there were significant differences, compare prostate with the estradiol benzoate group with the prostatic hyperplasia model group and the seminal vesicle index obviously reduces for of the present invention group, see Table 1.
Table 1 the present invention is to the influence of experimental prostatic hyperplasia (X ± SD)
* * compares p＜0.001 with normal control
△ compares p＜0.05 with model group
△ △ compares p＜0.01 with model group
2, to the influence of experimental hyperplastic prostate tissue form
As seen mirror is observed down, the blank group, and the body of gland number is few, and a matter does not have hypertrophy, and glandular epithelium is flat, and body of gland does not have expansion.Model group body of gland number increases, and glandular epithelium height hypertrophy forms many [s in lumen of gland, charges into the intracavity glandular cell and is high column, the outer proliferation of smooth muscle thickening of lumen of gland, proliferation of fibrous tissue between the lumen of gland.Rarely found papillae in the estradiol group lumen of gland, glandular cell is the doll shape, and smooth muscle and fibrous tissue do not see that hypertrophy sexually revises.Medicine group alveolar lumen and gland ductal ectasia degree obviously are lighter than preceding prostatic hyperplasia group, and outer smooth muscle tissue of lumen of gland and fibrous tissue are not seen obvious hypertrophy.Measure lumen of gland diameter, glandular epithelium height.See and come to the surface.The result shows the present invention, suppresses the prostate epithelial cell growth, and hyperplastic prostate tissue is dwindled.
Table 2 the present invention does the influence (X ± SD) of the epithelial cell height of gland hypertrophy disease lumen of gland diameter and gland before to rat experiment
* * compares p＜0.001 with matched group
△ compares p＜0.05 with model group
△ △ compares p＜0.01 with model group
△ △ △ compares p＜0.001 with model group
3, the influence of xylol induced mice auricular concha inflammation
The reaction that obviously reduces inflammation of aspirin group, heavy dose of group also has effect same among the present invention, learns by statistics and handles, and the present invention has the effect of auricular concha inflammation due to the remarkable inhibition dimethylbenzene, sees Table 3.
Table 3, the present invention are to the influence of mice ear (X ± SD)
* compare p＜0.05 with matched group
* compares p＜0.01 with matched group
* * compares p＜0.001 with matched group
Embodiment 1:A kind of preparation technology who treats the pure Chinese medicinal tablet of prostatosis
Prescription:
Cortex Phellodendri 200g Radix Paeoniae Rubra 200g Radix Salviae Miltiorrhizae 100g Semen Persicae 140g
Herba Lycopi 120g Radix Linderae 120g Semen Vaccariae 80g Radix Angelicae Dahuricae 80g
Method for making:
1, batching: by prescription each medicine is followed an example to do, weighing is placed respectively;
2, pulverize: get Cortex Phellodendri powder and be broken into fine powder and sieve standby (I);
3, decoct: get the Radix Linderae, the Herba Lycopi, the Radix Angelicae Dahuricae three flavor medicines are pressed steam distillation and are extracted volatile oil, and distillate is put in the brown bottle, airtight cold preservation.Separate volatile oil, mix during granulation in (I), alcohol,diluted was used when remaining aqueous solution supplied to granulate.Residue mixes with Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Semen Vaccariae, adds an amount of warm macerating 6h of water earlier, adds Semen Persicae when adding water again and being heated to about 80 ℃, continues heating and decocts, and extracts altogether three times, adds water for the first time and be 8 times of dosage, boils 2 hours; Be 6 times of amounts for the second time, 1.5 hours; Add 4 times of amounts of water for the third time, fried in shallow oil 1 hour.Secondary decocting liquid before merging leaves standstill, and filters, an amount of washing of the thing water that settles out three times.Washing liquid and filtrate merge, and are concentrated into nearly thick paste shape (II).It is an amount of to add water in the medicinal residues again, and warm macerating is centrifugal.Decocting liquid and centrifugal liquid merge for the third time, are concentrated into the thick paste shape and get (III);
4, mix: when treating that (III) is chilled to 60 ℃ of left and right sides, (II) added abundant stirring and evenly mixing in (III);
5, mixed thick paste is put (shop of trying to get to the heart of a matter is a small amount of with (I), morsel) in the baking tray, dry between 50-70 ℃, must the cream rate be about 20% after the oven dry, answer airtight preservation;
6, granulation, tabletting: dried cream powder is broken into crosses 16-18 mesh sieve (industry) behind the coarse powder, add (I) mixing, granulate in right amount with Diluted Alcohol, the granule water content is controlled between the 2-3%, behind the material all in one piece, add 0.7% magnesium stearate mix homogeneously, be pressed into 1000, every heavily about 0.3g is equivalent to the total crude drug amount of 1.04g;
7, sugar coating: operation routinely, the sealing coat Pulvis Talci, dyed layer is with 0.35% Tatrazine syrup, the heavily about 0.48g of coated tablet.
Embodiment 2:A kind of preparation technology who treats the pure Chinese medicine capsule preparation of prostatosis
Prescription:
Cortex Phellodendri 220g Radix Paeoniae Rubra 220g Radix Salviae Miltiorrhizae 80g Semen Persicae 160g
Herba Lycopi 120g Radix Linderae 120g Semen Vaccariae 60g Radix Angelicae Dahuricae 60g
Method for making:
1, batching: by prescription each medicine is followed an example to do, weighing is placed respectively;
2, pulverize: get Cortex Phellodendri powder and be broken into fine powder and sieve standby (I);
3, decoct: get the Radix Linderae, the Herba Lycopi, the Radix Angelicae Dahuricae three flavor medicines are pressed steam distillation and are extracted volatile oil, and distillate is put in the brown bottle, airtight cold preservation.Separate volatile oil, mix during granulation in (I), alcohol,diluted was used when remaining aqueous solution supplied to granulate.Residue mixes with Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Semen Vaccariae, adds an amount of warm macerating 6h of water earlier, adds Semen Persicae when adding water again and being heated to about 80 ℃, continues heating and decocts, and extracts altogether three times, adds water for the first time and be 8 times of dosage, boils 2 hours; Be 6 times of amounts for the second time, 1.5 hours; Add 4 times of amounts of water for the third time, fried in shallow oil 1 hour.Secondary decocting liquid before merging leaves standstill, and filters, an amount of washing of the thing water that settles out three times.Washing liquid and filtrate merge, and are concentrated into nearly thick paste shape (II).It is an amount of to add water in the medicinal residues again, and warm macerating is centrifugal.Decocting liquid and centrifugal liquid merge for the third time, are concentrated into the thick paste shape and get (III);
4, mix: when treating that (III) is chilled to 60 ℃ of left and right sides, (II) added abundant stirring and evenly mixing in (III);
5, mixed thick paste is put (shop of trying to get to the heart of a matter is a small amount of with (I), morsel) in the baking tray, dry between 50-70 ℃, must the cream rate be about 20% after the oven dry, answer airtight preservation;
6, extractum is pulverized the back and add (I) and adjuvant, mixing through final operation, is made 1000 of capsules.
Embodiment 3:A kind of preparation technology who treats the pure Chinese medicinal soft capsule preparation of prostatosis
Prescription:
Cortex Phellodendri 180g Radix Paeoniae Rubra 180g Radix Salviae Miltiorrhizae 80g Semen Persicae 160g
Herba Lycopi 140g Radix Linderae 140g Semen Vaccariae 80g Radix Angelicae Dahuricae 80g
Method for making
1, batching: by prescription each medicine is followed an example to do, weighing is placed respectively;
2, to be broken into fine powder standby for Cortex Phellodendri powder;
3, get Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae, when the Radix Angelicae Dahuricae is heated to 80 ℃, add Semen Persicae, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, drying is ground into fine powder;
4, add Cortex Phellodendri fine powder and adjuvant, mixing;
5, after pulverize, adding other adjuvants such as suspending agent, stabilizing agent, add vegetable oil, press grain, make 1000 of soft capsules.
Claims (4)
1. preparation method for the treatment of the oral preparation of Chinese traditional medicinal of prostatosis is characterized in that this method is:
Get crude drug:
Cortex Phellodendri 8～12 weight portion Radix Paeoniae Rubra 8～12 weight portion Radix Salviae Miltiorrhizaes 3～7 weight portions
Semen Persicae 5～9 weight portion Herba Lycopi 4～8 weight portion Radixs Linderae 4～8 weight portions
Semen Vaccariae 2～6 weight portion Radixs Angelicae Dahuricae 2～6 weight portions;
It is standby that Cortex Phellodendri powder is broken into fine powder; Get the Radix Linderae, Herba Lycopi, the Radix Angelicae Dahuricae three flavor medicines and extract volatile oil by steam distillation, raffinate is waited until alcohol,diluted and is used, residue mixes with Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Semen Vaccariae, adding water temperature earlier soaked 5-7 hour, adding Semen Persicae when adding water to 80 degree centigrade again continues to decoct 3-4 time, add water is dosage 4-8 times at every turn, decocts 1-2 hour, and it is stand-by to merge filtration simmer down to extractum; Volatile oil and extractum are mixed, and oven dry adds the Cortex Phellodendri fine powder and makes tablet, capsule, soft capsule, granule, pill or the powder of clinical acceptance.
2. preparation method as claimed in claim 1 is characterized in that crude drug is in this method:
Cortex Phellodendri 11 weight portion Radix Paeoniae Rubra 11 weight portion Radix Salviae Miltiorrhizaes 4 weight portions
The Semen Persicae 8 weight portion Herba Lycopi 6 weight portion Radixs Linderae 6 weight portions
The Semen Vaccariae 3 weight portion Radixs Angelicae Dahuricae 3 weight portions.
3. preparation method as claimed in claim 1 is characterized in that crude drug is in this method:
Cortex Phellodendri 9 weight portion Radix Paeoniae Rubra 9 weight portion Radix Salviae Miltiorrhizaes 4 weight portions
The Semen Persicae 8 weight portion Herba Lycopi 7 weight portion Radixs Linderae 7 weight portions
The Semen Vaccariae 4 weight portion Radixs Angelicae Dahuricae 4 weight portions.
4. as claim 1,2 or 3 described preparation methoies, it is characterized in that this method is:
It is standby that Cortex Phellodendri powder is broken into fine powder; Get the Radix Linderae, Herba Lycopi, the Radix Angelicae Dahuricae three flavor medicines and extract volatile oil by steam distillation, raffinate is waited until alcohol,diluted and is used, residue mixes with Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Semen Vaccariae, adding water temperature earlier soaked 6 hours, add Semen Persicae when adding water to 80 degree centigrade again and continue to decoct three times, adding water for the first time is that dosage decocted 2 hours for 8 times, is for the second time 6 times and decocts 1.5 hours, be 4 times for the third time and decocted 1 hour that it is stand-by to merge filtration simmer down to extractum; Volatile oil and extractum are mixed, and oven dry adds the Cortex Phellodendri fine powder and makes tablet, capsule, soft capsule, granule, pill or the powder of clinical acceptance.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100001354A CN100394939C (en) | 2004-01-06 | 2004-01-06 | Pure Chinese medicine oral preparation for treating prostate disease and its preparation metod |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100001354A CN100394939C (en) | 2004-01-06 | 2004-01-06 | Pure Chinese medicine oral preparation for treating prostate disease and its preparation metod |
Publications (2)
| Publication Number | Publication Date |
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| CN1555850A CN1555850A (en) | 2004-12-22 |
| CN100394939C true CN100394939C (en) | 2008-06-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2004100001354A Expired - Lifetime CN100394939C (en) | 2004-01-06 | 2004-01-06 | Pure Chinese medicine oral preparation for treating prostate disease and its preparation metod |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101322773B (en) * | 2008-07-24 | 2011-01-26 | 太原赛恩思科技发展有限公司 | Medicament for treating prostatic diseases |
| CN102210769A (en) * | 2010-04-05 | 2011-10-12 | 葫芦岛国帝药业有限责任公司 | Chinese medicinal composition for treating prostatitis |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1128151A (en) * | 1995-01-29 | 1996-08-07 | 万麟 | Pills for prostata disease |
| CN1362142A (en) * | 2001-01-05 | 2002-08-07 | 杨孟君 | Nano Niaosaitong medicine for dredging urethra and its preparation |
| CN1374107A (en) * | 2001-12-29 | 2002-10-16 | 郑国芃 | Chinese medicine for treating prostatitis, prostate hyperplasia and prostatauxe |
-
2004
- 2004-01-06 CN CNB2004100001354A patent/CN100394939C/en not_active Expired - Lifetime
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1128151A (en) * | 1995-01-29 | 1996-08-07 | 万麟 | Pills for prostata disease |
| CN1362142A (en) * | 2001-01-05 | 2002-08-07 | 杨孟君 | Nano Niaosaitong medicine for dredging urethra and its preparation |
| CN1374107A (en) * | 2001-12-29 | 2002-10-16 | 郑国芃 | Chinese medicine for treating prostatitis, prostate hyperplasia and prostatauxe |
Non-Patent Citations (8)
| Title |
|---|
| WS-10100-2002前列安通片. 国家中成药标准汇编，第外科妇科期. 2002 |
| WS-10100-2002前列安通片. 国家中成药标准汇编. 2002 |
| WS-10100-2002前列安通片. 国家中成药标准汇编，第外科妇科期. 2002 * |
| WS-10100-2002前列安通片. 国家中成药标准汇编. 2002 * |
| 乌药挥发油化学成分的GCMS 分析. 中草药，第34卷第4期. 2003 |
| 乌药挥发油化学成分的GCMS 分析. 中草药，第34卷第4期. 2003 * |
| 泽兰挥发油B 环糊精包合工艺研究. 南京中医药大学学报，第16卷第6期. 2000 |
| 泽兰挥发油B 环糊精包合工艺研究. 南京中医药大学学报，第16卷第6期. 2000 * |
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| CN1555850A (en) | 2004-12-22 |
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